WO2002080682A1 - Improved anti-inflammatory herbal composition and method of use - Google Patents

Improved anti-inflammatory herbal composition and method of use Download PDF

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Publication number
WO2002080682A1
WO2002080682A1 PCT/US2002/009477 US0209477W WO02080682A1 WO 2002080682 A1 WO2002080682 A1 WO 2002080682A1 US 0209477 W US0209477 W US 0209477W WO 02080682 A1 WO02080682 A1 WO 02080682A1
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Prior art keywords
extraα
weight
carbon dioxide
supercritical carbon
hydroalcohohc
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PCT/US2002/009477
Other languages
French (fr)
Inventor
Thomas Newmark
Paul Schulick
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New Chapter, Inc.
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Publication date
Application filed by New Chapter, Inc. filed Critical New Chapter, Inc.
Priority to KR10-2003-7012973A priority Critical patent/KR20030094318A/en
Priority to EP02726677A priority patent/EP1383386B1/en
Priority to CA2442964A priority patent/CA2442964C/en
Priority to AU2002257094A priority patent/AU2002257094B2/en
Priority to DE60228560T priority patent/DE60228560D1/en
Priority to JP2002578730A priority patent/JP4518740B2/en
Publication of WO2002080682A1 publication Critical patent/WO2002080682A1/en
Priority to HK04107127A priority patent/HK1064256A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/29—Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/539—Scutellaria (skullcap)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/718—Coptis (goldthread)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/82—Theaceae (Tea family), e.g. camellia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/906—Zingiberaceae (Ginger family)
    • A61K36/9068—Zingiber, e.g. garden ginger
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/04—Drugs for skeletal disorders for non-specific disorders of the connective tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Definitions

  • This invention relates to herbal compositions. More particularly, this invention relates to an herbal composition capable of reducing inflammation in bones and joints in animals, particularly humans. The present invention further relates to methods of using such herbal composition to reduce inflammation in bones and joints in animals, particularly humans.
  • Bone and joint inflammation is a scourge of both animals and humans. Those who suffer from inflammation experience pain and discomfort and may, in advanced cases, lose the effective use of inflamed joints. Thus, the goal of therapeutic methods for treating bone or joint inflammation is the relief of pain and discomfort and the restoration of use of inflamed joints.
  • Natural ingredients e.g., herbs
  • Natural ingredients have been used to treat bone and joint inflammation, especially in eastern countries, and, increasingly, in western countries.
  • Compositions composed of natural ingredients and said to be useful in reducing inflammation are disclosed, e.g., in U.S. Patent No ⁇ 5,494,668; 5,683,698; ⁇ ,916,565; 3,854,291; and 5,910,307.
  • U.S. Patent 5,494,668 discloses a method of treating degenerative musculoskeletal diseases such as rheumatoid arthritis and osteoarthritis in an animal, typically a human, involving administering (typically enterally) to the animal beneficiated extracts of the ashwagandha, sallai Guggul, turmeric, and ginger plants, in a predetermined proportion relative to each other with or without other biologically active inorganic ingredients.
  • U.S. Patent No. 5,683,698 discloses an orally a ⁇ mnistered herbal formulation for reducing or alleviating symptoms associated with rheumatoid arthritis, osteoarthritis, and reactive arthritis and for reducing the production of pro-inflammatory cytokines, wherein the formulation contains herbal extracts taken from Alpinia, Smilax, Tinospora, Tribulus, Wihania, and Zingiber plants. v
  • U.S. Patent No.5,916,565 discloses an orally administered composition for prophylaxis and therapy of joint and connective tissue disorders in vertebrates, wherein the composition contains metabolic precursors, herbal phytochemicals, and palatability agents.
  • herbal phytochemicals disclosed include cayenne, ginger, turmeric, yucca, Devil's claw, nettle leaf, Black Cohosh, alfalfa and celery seeds.
  • U.S. Patent No. 5,854,291 discloses a topically-applied pain reliever composition for treating such discomforts as arthritis pain, the composition being composed of capsaicin and, optionally, a plant extra ⁇ selected from the group consisting of nettle extra ⁇ , yarrow extra ⁇ , coltsfoot extra ⁇ , birch extra ⁇ , rosemary extra ⁇ , horsetail extra ⁇ , ginger extra ⁇ , chamomile extra ⁇ , comfrey extra ⁇ , lavender extra ⁇ , and bergamot extra ⁇ .
  • a plant extra ⁇ selected from the group consisting of nettle extra ⁇ , yarrow extra ⁇ , coltsfoot extra ⁇ , birch extra ⁇ , rosemary extra ⁇ , horsetail extra ⁇ , ginger extra ⁇ , chamomile extra ⁇ , comfrey extra ⁇ , lavender extra ⁇ , and bergamot extra ⁇ .
  • U.S. Patent No. 5,910,307 discloses a combined medicinal plant composition for alleviating acute/chronic inflammation, composed of Clematis Radix, Trichosanthes root, and Prunella Herba (which contains oleanolic acid ursolic acid) in a certain ratio.
  • Certain enzymes appear to play a role in causing inflammation.
  • One of the features of inflammation is increased oxygenation of arachidonic acid which is metabolized by two enzymic pathways - the cyclooxygenase (CO) and the 5-lipoxygenase (5-LO) pathways - leading to the produ ⁇ ion of prostaglandins and leukotrienes, respectively.
  • Prostaglandins and leukotrienes are mediators of inflammation. Therapies designed to inhibit cyclooxygenase and/or Iipoxygenase activity are therefore of great interest.
  • COX-1 cyclooxygenase-1
  • COX-2 cyclooxygenase-2
  • recent scientific studies also suggest that COX-2 inhibition may serve an important function in promoting normal cell growth in the colon, pancreas, breast tissue and other organ systems.
  • Non-steroidal anti-inflammatory drugs can have a variety of toxic side effects such as, e.g., gastric erosion and adverse effects on kidneys and liver, and may inadequately regulate the cellular immune functions and secretions of various cytokines.
  • Ursolic acid and oleanolic acid (less a ⁇ ive), the marker constituents of holy basil, have been found to a significant COX-2 inhibitory effe ⁇ .
  • Shogaol a pungent component of ginger, has been found to inhibit cyclooxygenase.
  • Eugenol another constituent of ginger, has also been found to be a 5-lipoxygenase inhibitor and to possess potent anti-inflammatory and/or anti-rheumatic properties.
  • Scutellaria baicalensis also has been found to inhibit the COX-2 enzyme.
  • green tea contains six constituents having cyclooxygenase-inhibitor a ⁇ ivity.
  • green tea contains fifty one constituents having anti-inflammatory activity.
  • the polyphenols in green tea were found to cause a marked reduction in cyclooxygenase-2.
  • Flavan-3-ol derivatives (+)-catechin, also present in green tea have been reported to be COX-1 and COX-2 inhibitors.
  • salicylic acid another constituent of green tea, also has been found to be a COX-2 inhibitor.
  • Inflammation is also mediated by oxygen-derived free radicals.
  • Free radicals degrade hyaluronic acid, modify collagen and perhaps proteogfycan structure and/or synthesis, alter and intera ⁇ with i munoglobulins, a ⁇ ivate degradative enzymes and inactivate their inhibitors, and possibly participate in chemotaxis. It is desirable to scavenge and detoxify free radicals before they reach the affected area.
  • Herbs which can scavenge free radicals include, e.g., holy basil, turmeric, huzhang, oregano, and scutellaria baicalensis.
  • a primary obje ⁇ of this invention is to provide an orally aclministered herbal composition capable of effectively reducing bone and joint inflammation in animals, particularly humans.
  • a further obje ⁇ of this invention is to provide the herbal composition set forth in the preceding obje ⁇ , wherein the composition reduces said inflammation by inhibiting COX-2.
  • Another obje ⁇ of this invention is to provide the herbal composition set forth in the preceding obje ⁇ s, wherein the composition is capable of reducing inflammation while avoiding the side effects associated with traditional drug therapy.
  • a further obje ⁇ of this invention is to provide the herbal composition set forth in the preceding obje ⁇ s, wherein the composition also has antioxidant properties.
  • a still further obje ⁇ of this invention is to provide the herbal composition described in the preceding obje ⁇ s, wherein the composition is composed of herbal extra ⁇ s that are prepared without chemical solvents.
  • Y ⁇ another obje ⁇ of this invention is to provide a method of reducing inflammation in animals (particularly humans) using an herbal composition having the properties set forth in the preceding obje ⁇ s.
  • the present invention is based on the discovery that a combination of certain herbs properly extra ⁇ ed and blended in appropriate proportions can provide improved anti-inflammatory benefits.
  • one aspe ⁇ of the present invention is dire ⁇ ed to an orally or topically administered herbal composition capable of reducing inflammation in animals, preferably humans, affli ⁇ ed with inflammation, the composition being composed of a therapeutically effe ⁇ ive amount of a post-supercritical carbon dioxide alcoholic extra ⁇ of ginger; therapeutically effective amounts of supercritical carbon dioxide extra ⁇ s of rosemary, turmeric, oregano and ginger (preferably certified organic ginger); and therapeutically effe ⁇ ive amounts of hydroalcoholic extra ⁇ s of holy basil, turmeric, scutellariae baicalensis, rosemary, green tea, huzhang (Pdygpm ⁇ n m ⁇ ddmi, Chinese goldthread, and barberry.
  • a second aspect of the present invention is dire ⁇ ed to a method for reducing inflammation in animals, preferably humans, suffering from inflammation, the method involving the steps of:
  • compositions (2) orally or topically administering the composition to the animal in an amount and for a time period effective to reduce inflammation in the animal.
  • composition of this invention reduces inflammation by inhibiting COX-2.
  • the composition not only reduces inflammation but also promotes healthy joint function and normal cell growth.
  • composition of this invention is capable of scavenging toxic active oxygen species, thereby providing antioxidant benefits.
  • composition of this invention can be prepared without the use of chemical solvents. This feature is achieved by using a supercritical solvent-free
  • the present invention provides an orally or topically administered herbal composition and a method of using the composition to reduce inflammation in animals, preferably humans, suffering from inflammation.
  • composition of this invention is composed of: a post-supercritical carbon dioxide alcoholic extra ⁇ of ginger; supercritical carbon dioxide extra ⁇ s of rosemary, turmeric, oregano and ginger (preferably certified organic ginger); and hydroalcoholic extra ⁇ s of holy basil, turmeric, scutellariae baicalensis, rosemary, green tea, huzhang, Chinese goldthread and barberry.
  • composition of this invention will contain "therapeutically effective amounts" of the herbal extra ⁇ s recited above.
  • therapeutically effective amount refers to that amount of the extra ⁇ which will contribute to the inflammation-reducing ability of the composition.
  • composition of this invention contains:
  • (B) from about 5.5% to about 8.5%, more preferably from about 6% to about 8%, by weight of a supercritical carbon dioxide extra ⁇ of ginger;
  • (C) from about 1.0% to about 1.5%, more preferably from about 1.2% to about 1.4%, by weight of a supercritical carbon dioxide extra ⁇ of turmeric;
  • the post-supercritical carbon dioxide alcoholic extra ⁇ of ginger used in the present invention is preferably prepared as follows.
  • the ginger rhizome which is preferably cryogenically ground to preserve heat sensitive components, is subjected to supercritical carbon dioxide extraction to obtain: (i) an oil extra ⁇ (referred to herein as "the supercritical carbon dioxide extra ⁇ " of ginger) containing delicate lipophilic (oil-soluble/non-polar) components, and ( ⁇ ) an oil-free residue.
  • the oil-free residue is then extra ⁇ ed in a water/alcohol (preferably water/ethanol) mixture (composed of 60-80 parts alcohol and 40-20 parts water).
  • a water/alcohol preferably water/ethanol
  • the alcohol/water liquid is then evaporated off, leaving a powdered extra ⁇ residue, referred to herein as "the post-supercritical carbon dioxide hydroalcoholic extra ⁇ " of ginger.
  • composition of this invention will preferably contain the supercritical carbon dioxide extra ⁇ and the post-supercritical carbon dioxide hydroalcoholic extra ⁇ of ginger at a weight ratio of preferably from about 0.9 to about 1.4 parts, more preferably from about 1.1 to about 1.3 parts, most preferably about 1.17 parts, of supercritical carbon dioxide extra ⁇ per 1 part post-supercritical carbon dioxide hydroalcoholic extra ⁇ .
  • the supercritical carbon dioxide extra ⁇ s of ginger, rosemary, turmeric and oregano used in the present invention can be prepared according to known supercritical carbon dioxide extraction methods, such as disclosed, e.g., in E. Stahl, K.W. Quirin, D. Gerard, Dense Gases for Extraction and Refining, Springer Verlag 1988, which is hereby incorporated by reference herein.
  • hydroalcoholic extracts of rosemary, turmeric, holy basil, green tea, huzhang, Chinese goldthread, barberry and scutellariae baicalensis used in the present invention can be prepared
  • the hydroalcoholic extra ⁇ s can be prepared by extracting the plant portion in a water/alcohol (preferably water/ethanol) mixture (preferably composed of 60-80 parts alcohol and 40-20 parts water), and then evaporating off the water/alcohol liquid, leaving a powdered extra ⁇ residue (referred to herein as "the hydroalcoholic extra ⁇ ").
  • a water/alcohol preferably water/ethanol
  • the hydroalcoholic extra ⁇ preferably composed of 60-80 parts alcohol and 40-20 parts water
  • the hydroalcoholic extra ⁇ of turmeric and the supercritical carbon dioxide extra ⁇ of turmeric will preferably be present at a weight ratio of preferably from about 8 to about 12 parts, more preferably from about 9 parts to about 11 parts, most preferably about 10 parts, of hydroalcoholic extra ⁇ per 1 part of supercritical carbon dioxide extra ⁇ .
  • composition of this invention will preferably contain the supercritical carbon dioxide extra ⁇ of rosemary and the hydroalcoholic extra ⁇ of rosemary at a weight ratio of preferably from about 1.6 to about 2.4 parts, more preferably from about 1.8 to about 2.2 parts, most preferably about 2.0 parts, of supercritical carbon dioxide extra ⁇ per 1 part of hydroalcoholic extra ⁇ .
  • the post-supercritical carbon dioxide hydroalcoholic extra ⁇ of ginger used in the present invention will preferably contain from about 2.4% to about 3.6%, more preferably from about 2.7% to about 3.3%, most preferably about 3.0%, by weight of pungent compounds (e.g., shogaol).
  • pungent compounds e.g., shogaol
  • the supercritical carbon dioxide extra ⁇ of ginger used in the present invention will contain preferably from about 24% to about 36%, more preferably from about 27% to about 33%, most preferably about 30%, by weight of pungent compounds (e.g., shogaol) and preferably from about 6.4% to about 9.6%, more preferably from about 7.2% to about 8.8%, most preferably about 8%, by weight of zingiberene.
  • pungent compounds e.g., shogaol
  • the supercritical carbon dioxide extra ⁇ of turmeric used in the present invention will contain preferably from about 36% to about 54%, more preferably from about 40.5% to about 49.5%, most preferably about 45%, by weight of turmerones.
  • the supercritical carbon dioxide extra ⁇ of rosemary used in the present invention will contain preferably from about 18.4% to about 27.6%, more preferably from about 20.7% to about 25.3%, most preferably about 23%, by weight of total phenolic antioxidants ("TPA").
  • the supercritical carbon dioxide extra ⁇ of oregano used in the present invention will contain preferably from about 0.64% to about 0.96%, more preferably from about 0.72% to about 0.88%, most preferably about 0.8%, by weight of TPA
  • the hydroalcoholic extra ⁇ of turmeric used in the present invention will contain preferably from about 5.6% to about 8.4%, more preferably from about 6.3% to about 7.7%, most preferably about 7%, by weight of curcumin.
  • the hydroalcoholic extra ⁇ of rosemary used in the present invention will contain preferably from about 18.4% to about 27.6%, more preferably from about 20.7% to about 25.3%, most preferably about 23%, by weight of TPA.
  • the hydroalcoholic extra ⁇ of holy basil used in the present invention will contain preferably from about 1.6% to about 2.4%, more preferably from about 1.8% to about 2.2%, most preferably about 2%, by weight of ursolic acid.
  • the hydroalcoholic extract of green tea used in the present invention will contain preferably from about 36% to about 54%, more preferably from about 40.5% to about 49.5%, most preferably about 45%, by weight of polyphenols.
  • the hydroalcoholic extract of huzhang used in the present invention will contain preferably from about 6.4% to about 9.6%, more preferably from about 7.2% to about 8.8%, most preferably about 8%, by weight of resveratrol.
  • the hydroalcoholic extract of Chinese goldthread used in the present invention will contain preferably from about 4.8% to about 7.2%, more preferably from about 5.4% to about 6.6%, most preferably about 6%, by weight of berberine.
  • the hydroalcoholic extract of barberry used in the present invention will contain preferably from about 4.8% to about 7.2%, more preferably from about 5.4% to about 6.6%, most preferably about 6%, by weight of berberine.
  • composition of this invention further contains a pharmaceutically acceptable carrier.
  • pharmaceutically acceptable carrier is meant to include one or more pharmaceutically suitable, inactive excipients, carriers, diluents, adjuvants, and lubricants.
  • Non-limiting examples of inactive excipients, carriers, diluents, lubricants, and adjuvants which can be used in the composition of the present invention include: cellulose, substituted cellulose, calcium carbonate, dicalcium phosphate, starches, la ⁇ ose, modified food starches, dextrose, calcium sulfate, magnesium carbonate, magnesium stearate, stearic acid, glycerin, vegetable oils, polysorbates, lecithin, silicium dioxide, food glaze, talc, croscarmellose sodium, povidone, water and gelatin. Additional inactive excipients, carriers, diluents, lubricants and adjuvants which may be used with the active-ingredient composition of this invention are disclosed
  • the pharmaceutically acceptable carrier can be present in any conventional amount used in an orally or topically administered compositions.
  • the present invention also provides a method for reducing inflammation in animals, preferably humans, suffering from inflammation.
  • the method of this invention involves the steps of: (1) providing the composition of this invention; and (2) orally or topically adrninistering the composition to the animal in an amount and for a time period effe ⁇ ive to reduce inflammation in the animal.
  • the herbal composition of this invention can be administered orally or topically (including ophtamically, vaginally, re ⁇ alry, intranasally, and the like).
  • the orally administered composition of this invention can be in any conventional form including, e.g., capsules (hard or soft), tablets, elixirs, powders, granules, suspensions in water or non-aqueous media, sachets, etc. Most preferably, the composition is in the form of one or more tablets, pills or capsules.
  • the composition of this invention is preferably orally ingested with a liquid, preferably water, more preferably with about 8 ounces of water.
  • Formulations for topical administration may include but are not limited to lotions, ointments, gels, creams, suppositories, drops, liquids, sprays, and powders.
  • Conventional pharmaceutical carriers; aqueous, powder or oily bases; thickeners and the like may be necessary or desirable.
  • the topically administered embodiment of the composition of this invention is in the form of a cream.
  • the active-ingredient portion of the composition ( ⁇ .e., the extra ⁇ s) is orally adrninistered in a daily dosage of at least about 500 mg, more preferably from about 700 mg to about 1000 mg, most preferably about 780 mg.
  • the daily dosage of the composition of this invention will contain preferably at least about 500 mg, more preferably from about 700 mg to about 1000 mg, most preferably about 780 mg, of the herbal extra ⁇ s.
  • Inactive ingredients can be present in the composition in amounts conventionally used in orally ingested dietary supplements.
  • the composition of this invention is preferably orally adrninistered for a period of at least about 4 weeks. If the composition is not taken on a daily basis, the effective period of time for reducing inflammation will take longer and will depend on the frequency of consumption and the amount consumed.
  • Turmeric hydroalcoholic rhizome 100 (7% cur ⁇ imin - 7 mg)
  • Ginger supercritical C0 2 rhizome 54 (30% pungent compounds - 16.2 mg 8% zingiberene - 4.3 mg)
  • Green tea hydroalcoholic leaf 100 (45% polyphenols - 45 mg)
  • Barberry hydroalcoholic root 40 (6% berberine - 2.4 mg)
  • composition set forth in the Table above will also include extra virgin olive oil and yellow beeswax
  • the capsule is composed of gelatin, vegetable glycerin, purified water and carob.
  • the two soft gel capsules (together constituting one serving) are preferably taken daily, with 8 ounces of water.

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Abstract

An orally or topically administered composition capable of reducing inflammation in animals, preferably humans, suffering from inflammation, contains a therapeutically effective amount of a post-supercritical carbon dioxide alcoholic extract of ginger; therapeutically effective amounts of supercritical carbon dioxide extracts of rosemary, turmeric, oregano and ginger (preferably certified organic ginger); and therapeutically effective amounts of hydroalcoholic extracts of holy basil, turmeric, scutellariae baicalensis, rosemary, green tea, huzhang, Chinese goldthread, and barberry. The composition is preferably orally administered on a daily basis for at least about 4 weeks.

Description

9510.101G
IMPROVED ANTI-INFLAMMATORY HERBAL COMPOSITION AND METHOD OF USE
Background of the Invention
This invention relates to herbal compositions. More particularly, this invention relates to an herbal composition capable of reducing inflammation in bones and joints in animals, particularly humans. The present invention further relates to methods of using such herbal composition to reduce inflammation in bones and joints in animals, particularly humans.
Arthritic disorders, including rheumatism, osteoarthritis, dysplasia, lupus, bursitis, and gout, are all characterized by inflammation and pain in bones, joints, muscles, and related connective tissues. Most of the forms are progressive. Bone and joint inflammation is a scourge of both animals and humans. Those who suffer from inflammation experience pain and discomfort and may, in advanced cases, lose the effective use of inflamed joints. Thus, the goal of therapeutic methods for treating bone or joint inflammation is the relief of pain and discomfort and the restoration of use of inflamed joints.
Natural ingredients, e.g., herbs, have been used to treat bone and joint inflammation, especially in eastern countries, and, increasingly, in western countries. Compositions composed of natural ingredients and said to be useful in reducing inflammation are disclosed, e.g., in U.S. Patent Noκ 5,494,668; 5,683,698; ^,916,565; 3,854,291; and 5,910,307.
U.S. Patent 5,494,668 (Patwardhan) discloses a method of treating degenerative musculoskeletal diseases such as rheumatoid arthritis and osteoarthritis in an animal, typically a human, involving administering (typically enterally) to the animal beneficiated extracts of the ashwagandha, sallai Guggul, turmeric, and ginger plants, in a predetermined proportion relative to each other with or without other biologically active inorganic ingredients.
U.S. Patent No. 5,683,698 (Chavali et al.) discloses an orally aα mnistered herbal formulation for reducing or alleviating symptoms associated with rheumatoid arthritis, osteoarthritis, and reactive arthritis and for reducing the production of pro-inflammatory cytokines, wherein the formulation contains herbal extracts taken from Alpinia, Smilax, Tinospora, Tribulus, Wihania, and Zingiber plants. v
U.S. Patent No.5,916,565 (Rose et al.) discloses an orally administered composition for prophylaxis and therapy of joint and connective tissue disorders in vertebrates, wherein the composition contains metabolic precursors, herbal phytochemicals, and palatability agents. Specific
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herbal phytochemicals disclosed include cayenne, ginger, turmeric, yucca, Devil's claw, nettle leaf, Black Cohosh, alfalfa and celery seeds.
U.S. Patent No. 5,854,291 (Laughlin, et al.) discloses a topically-applied pain reliever composition for treating such discomforts as arthritis pain, the composition being composed of capsaicin and, optionally, a plant extraα selected from the group consisting of nettle extraα, yarrow extraα, coltsfoot extraα, birch extraα, rosemary extraα, horsetail extraα, ginger extraα, chamomile extraα, comfrey extraα, lavender extraα, and bergamot extraα.
U.S. Patent No. 5,910,307 ( wak, et al.) discloses a combined medicinal plant composition for alleviating acute/chronic inflammation, composed of Clematis Radix, Trichosanthes root, and Prunella Herba (which contains oleanolic acid ursolic acid) in a certain ratio.
Certain enzymes appear to play a role in causing inflammation. One of the features of inflammation is increased oxygenation of arachidonic acid which is metabolized by two enzymic pathways - the cyclooxygenase (CO) and the 5-lipoxygenase (5-LO) pathways - leading to the produαion of prostaglandins and leukotrienes, respectively. Prostaglandins and leukotrienes are mediators of inflammation. Therapies designed to inhibit cyclooxygenase and/or Iipoxygenase activity are therefore of great interest.
There are two forms of the cyclooxygenase enzyme: cyclooxygenase- 1 (COX-1) and cyclooxygenase-2 (COX-2). The latter form, i.e., COX-2, appears to play a key role in inflammatory processes. Recent scientific studies suggest that inhibiting the COX-2 enzyme may be an effective way to reduce inflammation without the side effeαs associated with irreversible COX-1 inhibition. In addition, recent scientific studies also suggest that COX-2 inhibition may serve an important function in promoting normal cell growth in the colon, pancreas, breast tissue and other organ systems.
Drugs are being developed which are intended to selectively inhibit COX-2 with minimal effect on COX-1. However, despite the emphasis on COX-2 inhibition, these drugs appear to have serious side effeαs, e.g., a breakdown in digestive protective mucus and prevention of normal healing processes. For example, non-steroidal anti-inflammatory drugs (NSAIDS) can have a variety of toxic side effects such as, e.g., gastric erosion and adverse effects on kidneys and liver, and may inadequately regulate the cellular immune functions and secretions of various cytokines.
Several herbs have been found to inhibit the COX-2 enzyme.
For example, holy basil has been found to possess significant anti-inflammatory properties and is capable of blocking both the cyclooxygenase and Iipoxygenase pathways of arachidonate
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metabolism. Ursolic acid and oleanolic acid (less aαive), the marker constituents of holy basil, have been found to a significant COX-2 inhibitory effeα.
Shogaol, a pungent component of ginger, has been found to inhibit cyclooxygenase. Eugenol, another constituent of ginger, has also been found to be a 5-lipoxygenase inhibitor and to possess potent anti-inflammatory and/or anti-rheumatic properties.
Scutellaria baicalensis also has been found to inhibit the COX-2 enzyme.
According to the USDA database, green tea contains six constituents having cyclooxygenase-inhibitor aαivity. According to the Napralert database, green tea contains fifty one constituents having anti-inflammatory activity. The polyphenols in green tea were found to cause a marked reduction in cyclooxygenase-2. Flavan-3-ol derivatives (+)-catechin, also present in green tea, have been reported to be COX-1 and COX-2 inhibitors. In addition, salicylic acid, another constituent of green tea, also has been found to be a COX-2 inhibitor.
Berberine, found in barberry and Chinese goldthread, has been found to inhibit COX-2 without inhibiting COX-1 activity.
Inflammation is also mediated by oxygen-derived free radicals. Free radicals degrade hyaluronic acid, modify collagen and perhaps proteogfycan structure and/or synthesis, alter and interaα with i munoglobulins, aαivate degradative enzymes and inactivate their inhibitors, and possibly participate in chemotaxis. It is desirable to scavenge and detoxify free radicals before they reach the affected area.
Herbs which can scavenge free radicals include, e.g., holy basil, turmeric, huzhang, oregano, and scutellaria baicalensis.
Although herbs having anti-inflammatory properties are known, it is continually desirable to provide herbal compositions which have improved anti-inflammatory properties.
Accordingly, a primary objeα of this invention is to provide an orally aclministered herbal composition capable of effectively reducing bone and joint inflammation in animals, particularly humans.
A further objeα of this invention is to provide the herbal composition set forth in the preceding objeα, wherein the composition reduces said inflammation by inhibiting COX-2.
Another objeα of this invention is to provide the herbal composition set forth in the preceding objeαs, wherein the composition is capable of reducing inflammation while avoiding the side effects associated with traditional drug therapy.
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A further objeα of this invention is to provide the herbal composition set forth in the preceding objeαs, wherein the composition also has antioxidant properties.
A still further objeα of this invention is to provide the herbal composition described in the preceding objeαs, wherein the composition is composed of herbal extraαs that are prepared without chemical solvents.
Yα another objeα of this invention is to provide a method of reducing inflammation in animals (particularly humans) using an herbal composition having the properties set forth in the preceding objeαs.
These objeαs and others are achieved in the present invention.
Summary of the Invention
The present invention is based on the discovery that a combination of certain herbs properly extraαed and blended in appropriate proportions can provide improved anti-inflammatory benefits.
Accordingly, one aspeα of the present invention is direαed to an orally or topically administered herbal composition capable of reducing inflammation in animals, preferably humans, affliαed with inflammation, the composition being composed of a therapeutically effeαive amount of a post-supercritical carbon dioxide alcoholic extraα of ginger; therapeutically effective amounts of supercritical carbon dioxide extraαs of rosemary, turmeric, oregano and ginger (preferably certified organic ginger); and therapeutically effeαive amounts of hydroalcoholic extraαs of holy basil, turmeric, scutellariae baicalensis, rosemary, green tea, huzhang (Pdygpmøn mφddmi, Chinese goldthread, and barberry.
A second aspect of the present invention is direαed to a method for reducing inflammation in animals, preferably humans, suffering from inflammation, the method involving the steps of:
(1) providing the composition of this invention; and
(2) orally or topically administering the composition to the animal in an amount and for a time period effective to reduce inflammation in the animal.
The composition of this invention reduces inflammation by inhibiting COX-2. As a result, the composition not only reduces inflammation but also promotes healthy joint function and normal cell growth.
In addition, the composition of this invention is capable of scavenging toxic active oxygen species, thereby providing antioxidant benefits.
Another benefit provided by the composition of this invention is that it can be prepared without the use of chemical solvents. This feature is achieved by using a supercritical solvent-free
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extraction process to obtain the extraαs. Such extraαion process allows for the highest potency of active compounds in the extraαs, as much as 250 times the potency of the original fresh plant material.
Detailed Description of the Invention
As stated above, the present invention provides an orally or topically administered herbal composition and a method of using the composition to reduce inflammation in animals, preferably humans, suffering from inflammation.
The composition of this invention is composed of: a post-supercritical carbon dioxide alcoholic extraα of ginger; supercritical carbon dioxide extraαs of rosemary, turmeric, oregano and ginger (preferably certified organic ginger); and hydroalcoholic extraαs of holy basil, turmeric, scutellariae baicalensis, rosemary, green tea, huzhang, Chinese goldthread and barberry.
The composition of this invention will contain "therapeutically effective amounts" of the herbal extraαs recited above. As used herein with respeα to each of the herbal extraαs used in the composition of this invention, the term "therapeutically effective amount" refers to that amount of the extraα which will contribute to the inflammation-reducing ability of the composition.
Preferably, the composition of this invention contains:
(A) from about 4.5% to about 7.5%, more preferably from about 5.5% to about 6.5%, by weight of a post-supercritical carbon dioxide alcoholic extraα of ginger,
(B) from about 5.5% to about 8.5%, more preferably from about 6% to about 8%, by weight of a supercritical carbon dioxide extraα of ginger;
(C) from about 1.0% to about 1.5%, more preferably from about 1.2% to about 1.4%, by weight of a supercritical carbon dioxide extraα of turmeric;
(D) from about 10.0% to about 16.0%, more preferably from about 11.5% to about 14.5%, by weight of a supercritical carbon dioxide extraα of rosemary;
(E) from about 4.0% to about 6.0%, more preferably from about 4.5% to about 5.5%, by weight of a supercritical carbon dioxide extraα of oregano;
(F) from about 10.0% to about 16.0%, more preferably from about 11.5% to about 14.5%, by weight of a hydroalcoholic extraα of turmeric;
(G) from about 5.5% to about 8.0%, more preferably from about 6.0% to about 7.0%, by weight of a hydroalcoholic extraα of rosemary;
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(H) from about 10.0% to about 16.0%, more preferably from about 11.5% to about 14.5%, by weight of a hydroalcoholic extract of holy basil;
(I) from about 10.0% to about 16.0%, more preferably from about 11.5% to about 14.5%, by weight of a hydroalcoholic extract of green tea;
0) from about 8.0% to about 12.0%, more preferably from about 9.0% to about 11.0%, by weight of a hydroalcoholic extraα of huzhang;
(K) from about 4.0% to about 6.0%, more preferably from about 4.5% to about 5.5%, by weight of a hydroalcoholic extraα of Chinese goldthread;
(L) from about 4.0% to about 6.0%, more preferably from about 4.5% to about 5.5%, by weight of a hydroalcoholic extraα of barberry; and
(M) from about 2.0% to about 3.0%, more preferably from about 2.25% to about 2.75%, by weight of a hydroalcoholic extraα of scutellariae baicalensis. The post-supercritical carbon dioxide alcoholic extraα of ginger used in the present invention is preferably prepared as follows. The ginger rhizome, which is preferably cryogenically ground to preserve heat sensitive components, is subjected to supercritical carbon dioxide extraction to obtain: (i) an oil extraα (referred to herein as "the supercritical carbon dioxide extraα" of ginger) containing delicate lipophilic (oil-soluble/non-polar) components, and (ϋ) an oil-free residue. The oil-free residue is then extraαed in a water/alcohol (preferably water/ethanol) mixture (composed of 60-80 parts alcohol and 40-20 parts water). The alcohol/water liquid is then evaporated off, leaving a powdered extraα residue, referred to herein as "the post-supercritical carbon dioxide hydroalcoholic extraα" of ginger.
The composition of this invention will preferably contain the supercritical carbon dioxide extraα and the post-supercritical carbon dioxide hydroalcoholic extraα of ginger at a weight ratio of preferably from about 0.9 to about 1.4 parts, more preferably from about 1.1 to about 1.3 parts, most preferably about 1.17 parts, of supercritical carbon dioxide extraα per 1 part post-supercritical carbon dioxide hydroalcoholic extraα.
The supercritical carbon dioxide extraαs of ginger, rosemary, turmeric and oregano used in the present invention can be prepared according to known supercritical carbon dioxide extraction methods, such as disclosed, e.g., in E. Stahl, K.W. Quirin, D. Gerard, Dense Gases for Extraction and Refining, Springer Verlag 1988, which is hereby incorporated by reference herein.
The hydroalcoholic extracts of rosemary, turmeric, holy basil, green tea, huzhang, Chinese goldthread, barberry and scutellariae baicalensis used in the present invention can be prepared
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according to conventional hydroalcoholic extraction techniques. For example, the hydroalcoholic extraαs can be prepared by extracting the plant portion in a water/alcohol (preferably water/ethanol) mixture (preferably composed of 60-80 parts alcohol and 40-20 parts water), and then evaporating off the water/alcohol liquid, leaving a powdered extraα residue (referred to herein as "the hydroalcoholic extraα").
In the composition of this invention, the hydroalcoholic extraα of turmeric and the supercritical carbon dioxide extraα of turmeric will preferably be present at a weight ratio of preferably from about 8 to about 12 parts, more preferably from about 9 parts to about 11 parts, most preferably about 10 parts, of hydroalcoholic extraα per 1 part of supercritical carbon dioxide extraα.
The composition of this invention will preferably contain the supercritical carbon dioxide extraα of rosemary and the hydroalcoholic extraα of rosemary at a weight ratio of preferably from about 1.6 to about 2.4 parts, more preferably from about 1.8 to about 2.2 parts, most preferably about 2.0 parts, of supercritical carbon dioxide extraα per 1 part of hydroalcoholic extraα.
The post-supercritical carbon dioxide hydroalcoholic extraα of ginger used in the present invention will preferably contain from about 2.4% to about 3.6%, more preferably from about 2.7% to about 3.3%, most preferably about 3.0%, by weight of pungent compounds (e.g., shogaol).
The supercritical carbon dioxide extraα of ginger used in the present invention will contain preferably from about 24% to about 36%, more preferably from about 27% to about 33%, most preferably about 30%, by weight of pungent compounds (e.g., shogaol) and preferably from about 6.4% to about 9.6%, more preferably from about 7.2% to about 8.8%, most preferably about 8%, by weight of zingiberene.
The supercritical carbon dioxide extraα of turmeric used in the present invention will contain preferably from about 36% to about 54%, more preferably from about 40.5% to about 49.5%, most preferably about 45%, by weight of turmerones.
The supercritical carbon dioxide extraα of rosemary used in the present invention will contain preferably from about 18.4% to about 27.6%, more preferably from about 20.7% to about 25.3%, most preferably about 23%, by weight of total phenolic antioxidants ("TPA").
The supercritical carbon dioxide extraα of oregano used in the present invention will contain preferably from about 0.64% to about 0.96%, more preferably from about 0.72% to about 0.88%, most preferably about 0.8%, by weight of TPA
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The hydroalcoholic extraα of turmeric used in the present invention will contain preferably from about 5.6% to about 8.4%, more preferably from about 6.3% to about 7.7%, most preferably about 7%, by weight of curcumin.
The hydroalcoholic extraα of rosemary used in the present invention will contain preferably from about 18.4% to about 27.6%, more preferably from about 20.7% to about 25.3%, most preferably about 23%, by weight of TPA.
The hydroalcoholic extraα of holy basil used in the present invention will contain preferably from about 1.6% to about 2.4%, more preferably from about 1.8% to about 2.2%, most preferably about 2%, by weight of ursolic acid.
The hydroalcoholic extract of green tea used in the present invention will contain preferably from about 36% to about 54%, more preferably from about 40.5% to about 49.5%, most preferably about 45%, by weight of polyphenols.
The hydroalcoholic extract of huzhang used in the present invention will contain preferably from about 6.4% to about 9.6%, more preferably from about 7.2% to about 8.8%, most preferably about 8%, by weight of resveratrol.
The hydroalcoholic extract of Chinese goldthread used in the present invention will contain preferably from about 4.8% to about 7.2%, more preferably from about 5.4% to about 6.6%, most preferably about 6%, by weight of berberine.
The hydroalcoholic extract of barberry used in the present invention will contain preferably from about 4.8% to about 7.2%, more preferably from about 5.4% to about 6.6%, most preferably about 6%, by weight of berberine.
In preferred embodiments, the composition of this invention further contains a pharmaceutically acceptable carrier. As used herein, the term "pharmaceutically acceptable carrier" is meant to include one or more pharmaceutically suitable, inactive excipients, carriers, diluents, adjuvants, and lubricants. Non-limiting examples of inactive excipients, carriers, diluents, lubricants, and adjuvants which can be used in the composition of the present invention include: cellulose, substituted cellulose, calcium carbonate, dicalcium phosphate, starches, laαose, modified food starches, dextrose, calcium sulfate, magnesium carbonate, magnesium stearate, stearic acid, glycerin, vegetable oils, polysorbates, lecithin, silicium dioxide, food glaze, talc, croscarmellose sodium, povidone, water and gelatin. Additional inactive excipients, carriers, diluents, lubricants and adjuvants which may be used with the active-ingredient composition of this invention are disclosed
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in the Handbook of Food Additives (CRC Press), which is incorporated by reference herein in relevant part.
The pharmaceutically acceptable carrier can be present in any conventional amount used in an orally or topically administered compositions.
The present invention also provides a method for reducing inflammation in animals, preferably humans, suffering from inflammation. The method of this invention involves the steps of: (1) providing the composition of this invention; and (2) orally or topically adrninistering the composition to the animal in an amount and for a time period effeαive to reduce inflammation in the animal.
The herbal composition of this invention can be administered orally or topically (including ophtamically, vaginally, reαalry, intranasally, and the like).
The orally administered composition of this invention can be in any conventional form including, e.g., capsules (hard or soft), tablets, elixirs, powders, granules, suspensions in water or non-aqueous media, sachets, etc. Most preferably, the composition is in the form of one or more tablets, pills or capsules.
If in tablet, pill or capsule form, the composition of this invention is preferably orally ingested with a liquid, preferably water, more preferably with about 8 ounces of water.
Formulations for topical administration may include but are not limited to lotions, ointments, gels, creams, suppositories, drops, liquids, sprays, and powders. Conventional pharmaceutical carriers; aqueous, powder or oily bases; thickeners and the like may be necessary or desirable. Most preferably, the topically administered embodiment of the composition of this invention is in the form of a cream.
Preferably, the active-ingredient portion of the composition (ι.e., the extraαs) is orally adrninistered in a daily dosage of at least about 500 mg, more preferably from about 700 mg to about 1000 mg, most preferably about 780 mg. In other words, the daily dosage of the composition of this invention will contain preferably at least about 500 mg, more preferably from about 700 mg to about 1000 mg, most preferably about 780 mg, of the herbal extraαs. Inactive ingredients can be present in the composition in amounts conventionally used in orally ingested dietary supplements.
If consumed on a daily basis, the composition of this invention is preferably orally adrninistered for a period of at least about 4 weeks. If the composition is not taken on a daily basis, the effective period of time for reducing inflammation will take longer and will depend on the frequency of consumption and the amount consumed.
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Set forth in the Table below is a preferred embodiment of the orally adrninistered composition (excluding inactive ingredients) of this invention. The amounts recited in the Table represent the preferred daily dosage (and one serving) of the ingredients listed.
TABLE
Herb Type Plant Part Amount Of Extraα irng
Rosemary supercritical COz leaf 100
Rosemary hydroalcoholic leaf 50 (23% TPA - 34.5 mg)
Turmeric supercritical C02 rhizome 10 (45% turmerones - 4.5 mg)
Turmeric hydroalcoholic rhizome 100 (7% curαimin - 7 mg)
Ginger supercritical C02 rhizome 54 (30% pungent compounds - 16.2 mg 8% zingiberene - 4.3 mg)
Ginger post-supercritical rhizome 46 COz hydroalcoholic (3% pungent compounds - 1.4 mg)
Holy basil hydroalcoholic leaf 100 (2% ursolic acid - 2 mg)
Green tea hydroalcoholic leaf 100 (45% polyphenols - 45 mg)
Huzhang hydroalcoholic root : & rhizome 80 (8% resveratrol - 6.4 mg)
Chinese Goldthread hydroalcoholic root 40 (6% berberine - 2.4 mg)
Barberry hydroalcoholic root 40 (6% berberine - 2.4 mg)
Oregano supercritical C02 leaf 40 (0.8% TPA - 0.32 mg)
Scutellariae
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Baicalensis hydroalcoholic root 20
(5:1)
Preferably, the composition set forth in the Table above will also include extra virgin olive oil and yellow beeswax
In preferred embodiments of the soft gel capsule form of the present invention, the capsule is composed of gelatin, vegetable glycerin, purified water and carob.
For oral aoministration of the above-recited formulation, the two soft gel capsules (together constituting one serving) are preferably taken daily, with 8 ounces of water.
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Claims

9510.101GWhat is claimed is:
1. An orally or topically aclministered herbal composition capable of reducing inflammation in an animal, suffering from inflammation, comprising: a therapeutically effeαive amount of a post-supercritical carbon dioxide alcoholic extraα of ginger; therapeutically effective amounts of supercritical carbon dioxide extraαs of rosemary, turmeric, oregano and ginger; and therapeutically effective amounts of hydroalcoholic extraαs of holy basil, turmeric, scutellariae baicalensis, rosemary, green tea, huzhang, Chinese goldthread, and barberry.
2. A composition according to claim 1, wherein the composition is an orally adrninistered composition.
3. A composition according to claim 2, wherein the composition is in the form of one or more capsules, one or more tablets, or one or more pills.
4. A composition according to claim 2, comprising:
(A) from about 4.5% to about 7.5% by weight of the post-supercritical carbon dioxide alcoholic extraα of ginger
(B) from about 5.5% to about 8.5% by weight of the supercritical carbon dioxide extraα of ginger;
(C) from about 1.0% to about 1.5% by weight of the supercritical carbon dioxide extraα of turmeric;
(D) from about 10.0% to about 16.0% by weight of the supercritical carbon dioxide extraα of rosemary;
(E) from about 4.0% to about 6.0% by weight of the supercritical carbon dioxide extraα of oregano;
(F) from about 10.0% to about 16.0% by weight of the hydroalcoholic extraα of turmeric;
(G) from about 5.5% to about 8.0% by weight of the hydroalcoholic extraα of rosemary,
(H) from about 10.0% to about 16.0% by weight of the hydroalcoholic extraα of holy basil;
(I) from about 10.0% to about 16.0% by weight of the hydroalcoholic extraα of green tea;
0) from about 8.0% to about 12.0% by weight of the hydroalcoholic extraα of huzhang;
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(K) from about 4.0% to about 6.0% by weight of the hydroalcoholic extraα of Chinese goldthread;
(L) from about 4.0% to about 6.0% by weight of the hydroalcoholic extraα of barberry and
(M) from about 2.0% to about 3.0% by weight of the hydroalcoholic extraα of scutellariae baicalensis. 5. A composition according to claim 2, comprising:
(A) from about 5.5% to about 6.5% by weight of the post-supercritical carbon dioxide alcoholic extraα of ginger;
(B) from about 6% to about 8% by weight of the supercritical carbon dioxide extraα of ginger;
(C) from about 1.2% to about 1.4% by weight of the supercritical carbon dioxide extraα of turmeric;
(D) from about 11.5% to about 14.5% by weight of the supercritical carbon dioxide extraα of rosemary;
(E) from about 4.5% to about 5.5% by weight of the supercritical carbon dioxide extraα of oregano;
(F) from about 11.5% to about 14.5% by weight of the hydroalcoholic extraα of turmeric;
(G) from about 6.0% to about 7.0% by weight of the hydroalcoholic extraα of rosemary;
(H) from about 11.5% to about 14.5% by weight of the hydroalcoholic extraα of holy basil;
(I) from about 11.5% to about 14.5% by weight of the hydroalcoholic extraα of green tea;
0) from about 9.0% to about 11.0% by weight of the hydroalcoholic extraα of huzhang;
(K) from about 4.5% to about 5.5% by weight of the hydroalcoholic extraα of Chinese goldthread;
(L) from about 4.5% to about 5.
5% by weight of the hydroalcoholic extraα of barberry, and
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(M) from about 2.25% to about 2.75% by weight of the hydroalcoholic extraα of scutellariae baicalensis.
6. A composition according to claim 2, wherein the composition comprises the supercritical carbon dioxide extraα of ginger and the post-supercritical carbon dioxide hydroalcoholic extraα of ginger at a weight ratio of from about 0.9 to about 1.4 parts of supercritical carbon dioxide extraα per 1 part of post-supercritical carbon dioxide hydroalcoholic extraα.
7. A composition according to claim 2, wherein the composition comprises the hydroalcoholic extraα of turmeric and the supercritical carbon dioxide extraα of turmeric at a weight ratio of from about 8 to about 12 parts of hydroalcoholic extraα per 1 part of supercritical carbon dioxide extraα.
8. A composition according to claim 2, wherein the composition comprises the supercritical carbon dioxide extraα of rosemary and the hydroalcoholic extraα of rosemary at a weight ratio of from about 1.6 to about 2.4 parts of supercritical carbon dioxide extraα per 1 part of hydroalcoholic extraα.
9. A composition according to claim 2, wherein the post-supercritical carbon dioxide hydroalcoholic extraα of ginger comprises from about 2.4% to about 3.6% by weight of pungent compounds.
10. A composition according to claim 2, wherein the supercritical carbon dioxide extraα of ginger comprises from about 24% to about 36% by weight of pungent compounds and from about 6.4% to about 9.6% by weight, of zingiberene.
11. A composition according to claim 2, wherein the supercritical carbon dioxide extraα of turmeric comprises from about 36% to about 54% by weight of turmerones.
12. A composition according to claim 2, wherein the supercritical carbon dioxide extraα of rosemary comprises from about 18.4% to about 27.6% by weight of total phenolic antioxidants.
13. A composition according to claim 2, wherein the supercritical carbon dioxide extraα of oregano comprises from about 0.64% to about 0.96% by weight of total phenolic antioxidants.
14. A composition according to claim 2, wherein the hydroalcoholic extraα of turmeric comprises from about 5.6% to about 8.4% by weight of curcumin.
15. A composition according to claim 2, wherein the hydroalcoholic extraα of rosemary comprises from about 18.4% to about 27.6% by weight of total phenolic antioxidants.
16. A composition according to claim 2, wherein the hydroalcoholic extraα of holy basil comprises from about 1.6% to about 2.4% by weight of ursolic acid.
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17. A composition according to claim 2, wherein the hydroalcohohc extraα of green tea comprises from about 36% to about 54% by weight of polyphenols.
18. A composition according to claim 2, wherein the hydroalcohohc extraα of huzhang comprises from about 6.4% to about 9.6% by weight of resveratrol.
19. A composition according to claim 2, wherein the hydroalcohohc extraα of Chinese goldthread comprises from about 4.8% to about 7.2% by weight of berberine.
20. A composition according to claim 2, wherein the hydroalcohohc extraα of barberry comprises from about 4.8% to about 7.2% by weight of berberine.
21. A composition according to claim 2, comprising:
(A) from about 4.5% to about 7.5% by weight of the post-supercritical carbon dioxide alcoholic extraα of ginger, wherein the extraα comprises from about 2.4% to about 3.6% by weight of pungent compounds;
(B) from about 5.5% to about 8.5% by weight of the supercritical carbon dioxide extraα of ginger, wherein the extraα comprises from about 24% to about 36% by weight of pungent compounds and from about 6.4% to about 9.6% by weight of zingiberene;
(C) from about 1.0% to about 1.5% by weight of the supercritical carbon dioxide extraα of turmeric, wherein the extraα comprises from about 36% to about 54% by weight of turmerones.;
(D) from about 10.0% to about 16.0% by weight of the supercritical carbon dioxide extraα of rosemary, wherein the extraα comprises from about 18.4% to about 27.6% by weight of total phenolic antioxidants;
(E) from about 4.0% to about 6.0% by weight of the supercritical carbon dioxide extraα of oregano, wherein the extraα comprises from about 0.64% to about 0.96% by weight of total phenolic antioxidants;
(F) from about 10.0% to about 16.0% by weight of the hydroalcoholic extraα of turmeric, wherein the extraα comprises from about 5.6% to about 8.4% by weight of curcumin;
(G) from about 5.5% to about 8.0% by weight of the hydroalcohohc extraα of rosemary, wherein the extraα comprises from about 18.4% to about 27.6% by weight of total phenolic antioxidants;
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(H) from about 10.0% to about 16.0% by weight of the hydroalcohohc extraα of holy basil, wherein the extraα comprises from about 1.6% to about 2.4% by weight of ursolic acid;
0) from about 10.0% to about 16.0% by weight of the hydroalcohohc extraα of green tea, wherein the extraα comprises from about 36% to about 54% by weight of polyphenols;
0) from about 8.0% to about 12.0% by weight of the hydroalcohohc extraα of huzhang, wherein the extraα comprises from about 6.4% to about 9.6% by weight of resveratrol;
(K) from about 4.0% to about 6.0% by weight of the hydroalcohohc extraα of Chinese goldthread, wherein the extraα from about 4.8% to about 7.2% by weight of berberine;
(L) from about 4:0% to about 6.0% by weight of the hydroalcohohc extraα of barberry, wherein the extraα from about 4.8% to about 7.2% by weight of berberine; and
(M) from about 2.0% to about 3.0% by weight of the hydroalcohohc extraα of scutellariae baicalensis; further wherein the composition comprises: (i) the supercritical carbon dioxide extraα of ginger and the post-supercritical carbon dioxide hydroalcohohc extraα of ginger at a weight ratio of from about 0.9 to about 1.4 parts of supercritical carbon dioxide extraα per 1 part of post- supercritical carbon dioxide hydroalcohohc extraα; (ϋ) the hydroalcohohc extraα of turmeric and the supercritical carbon dioxide extraα of turmeric at a weight ratio of from about 8 to about 12 parts of hydroalcohohc extraα per 1 part of supercritical carbon dioxide extract; and (hi) the supercritical carbon dioxide extraα of rosemary and the hydroalcohohc extraα of rosemary at a weight ratio of from about 1.6 to about 2.4 parts of supercritical carbon dioxide extraα per 1 part of hydroalcoholic extraα.
22. A method for reducing inflammation in an animal suffering from inflammation, comprising the steps of:
(1) providing the composition of claim 1; and
(2) orahy or topically administering the composition to the animal in an amount and for a time period sufficient to reduce the inflammation. -
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23. A method according to claim 22, wherein the composition provided in step (1) is in an orally administered form, and step (2) comprises orally administering the composition to a human.
24. A method according to claim 23, wherein the orally adrninistered composition provided in step (1) is in the form of one or more capsules, one or more tablets, or one or more pills. "
25. A method according to claim 23, wherein the orally administered composition provided in step (1) comprises:
(A) from about 4.5% to about 7.5% by weight of the post-supercritical carbon dioxide alcoholic extraα of ginger;
(B) from about 5.5% to about 8.5% by weight of the supercritical carbon dioxide extraα of ginger;
(C) from about 1.0% to about 1.5% by weight of the supercritical carbon dioxide extraα of turmeriς
(D) from about 10.0% to about 16.0% by weight of the supercritical carbon dioxide extraα of rosemary;
(E) from about 4.0% to about 6.0% by weight of the supercritical carbon dioxide extraα of oregano;
(F) from about 10.0% to about 16.0% by weight of the hydroalcohohc extraα of turmeric;
(G) from about 5.5% to about 8.0% by weight of the hydroalcohohc extraα of rosemary;
(H) from about 10.0% to about 16.0% by weight of the hydroalcohohc extraα of holy basil;
(I) from about 10.0% to about 16.0% by weight of the hydroalcohohc extraα of green tea;
0) from about 8.0% to about 12.0% by weight of the hydroalcohohc extraα of huzhang;
( ) from about 4.0% to about 6.0% by weight of the hydroalcohohc extraα of Chinese goldthread
(L) from about 4.0% to about 6.0% by weight of the hydroalcohohc extraα of barberry; and
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(M) from about 2.0% to about 3.0% by weight of the hydroalcohohc extraα of scutellariae baicalensis.
26. A method according to claim 23, wherein the composition provided in step (1) comprises the supercritical carbon dioxide extraα of ginger and the post-supercritical carbon dioxide hydroalcohohc extraα of ginger at a weight ratio of from about 0.9 to about 1.4 parts of supercritical carbon dioxide extraα per 1 part of post-supercritical carbon dioxide hydroalcohohc extraα.
27. A method according to claim 23, wherein the composition provided in step (1) comprises the hydroalcohohc extraα of turmeric and the supercritical carbon dioxide extraα of turmeric at a weight ratio of from about 8 to about 12 parts of hydroalcohohc extraα per 1 part of supercritical carbon dioxide extraα.
28. A method according to claim 23, wherein the composition provided in step (1) comprises the supercritical carbon dioxide extraα of rosemary and the hydroalcohohc extraα of rosemary at a weight ratio of from about 1.6 to about 2.4 parts of supercritical carbon dioxide extraα per 1 part of hydroalcohohc extraα.
29. A method according to claim 23, wherein, in the composition provided in step (1), the post-supercritical carbon dioxide hydroalcohohc extraα of ginger comprises from about 2.4% to about 3.6% by weight of pungent compounds.
30. A method according to claim 23, wherein, in the composition provided in step (1), the supercritical carbon dioxide extraα of ginger comprises from about 24% to about 36% by weight of pungent compounds and from about 6.4% to about 9.6% by weight of zingiberene.
31. A method according to claim 23, wherein, in the composition provided in step (1), the supercritical carbon dioxide extraα of turmeric comprises from about 36% to about 54% by weight of turmerones.
32. A method according to claim 23, wherein, in the composition provided in step (1), the supercritical carbon dioxide extraα of rosemary comprises from about 18.4% to about 27.6% by weight of total phenolic antioxidants.
33. A method according to claim 23, wherein, in the composition provided in step (1), the supercritical carbon dioxide extraα of oregano comprises from about 0.64% to about 0.96% by weight of total phenolic antioxidants.
34. A method according to claim 23, wherein, in the composition provided in step (1), the hydroalcohohc extraα of turmeric comprises from about 5.6% to about 8.4% by weight of curcumin.
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35. A method according to claim 23, wherein, in the composition provided in step (1), the hydroalcohohc extraα of rosemary comprises from about 18.4% to about 27.6% by weight of total phenolic antioxidants.
36. A method according to claim 23, wherein, in the composition provided in step (1), the hydroalcohohc extraα of holy basil comprises from about 1.6% to about 2.4% by weight of ursolic acid.
37. A method according to claim 23, wherein, in the composition provided in step (1), the hydroalcohohc extraα of green tea comprises from about 36% to about 54% by weight of polyphenols.
38. A method according to claim 23, wherein, in the composition provided in step (1), the hydroalcohohc extraα of huzhang comprises from about 6.4% to about 9.6% by weight of resveratrol.
39. A method according to claim 23, wherein, in the composition provided in step (1), the hydroalcohohc extraα of Chinese goldthread comprises from about 4.8% to about 7.2% by weight of berberine.
40. A method according to claim 23, wherein, in the composition provided in step (1), the hydroalcohohc extraα of barberry comprises from about 4.8% to about 7.2% by weight of berberine.
41. A method according to claim 23, wherein the composition provided in step (1) compnses:
(A) from about 4.5% to about 7.5% by weight of the post-supercritical carbon dioxide alcoholic extraα of ginger, wherein the extraα comprises from about 2.4% to about 3.6% by weight of pungent compounds;
(B) from about 5.5% to about 8.5% by weight of the supercritical carbon dioxide extraα of ginger, wherein the extraα comprises from about 24% to about 36% by weight of pungent compounds and from about 6.4% to about 9.6% by weight of zingiberene;
(C) from about 1.0% to about 1.5% by weight of the supercritical carbon dioxide extraα of turmeric, wherein the extraα comprises from about 36% to about 54% by weight of turmerones.;
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(D) from about 10.0% to about 16.0% by weight of the supercritical carbon dioxide extraα of rosemary, wherein the extraα comprises from about 18.4% to about 27.6% by weight of total phenolic antioxidants;
(E) from about 4.0% to about 6.0% by weight of the supercritical carbon dioxide extraα of oregano, wherein the extraα comprises from about 0.64% to about 0.96% by weight of total phenolic antioxidants;
(F) from about 10.0% to about 16.0% by weight of the hydroalcohohc extraα of turmeric, wherein the extraα comprises from about 5.6% to about 8.4% by weight of curcumin;
(G) from about 5.5% to about 8.0% by weight of the hydroalcohohc extraα of rosemary, wherein the extraα comprises from about 18.4% to about 27.6% by weight of total phenolic antioxidants;
(H) from about 10.0% to about 16.0% by weight of the hydroalcohohc extraα of holy basil, wherein the extraα comprises from about 1.6% to about 2.4% by weight of ursolic acid;
0) from about 10.0% to about 16.0% by weight of the hydroalcohohc extraα of green tea, wherein the extraα comprises from about 36% to about 54% by weight of polyphenols;
0) from about 8.0% to about 12.0% by weight of the hydroalcohohc extraα of huzhang, wherein the extraα comprises from about 6.4% to about 9.6% by weight of resveratrol;
(K) from about 4.0% to about 6.0% by weight of the hydroalcohohc extraα of Chinese goldthread, wherein the extraα from about 4.8% to about 7.2% by weight of berberine;
(L) from about 4.0% to about 6.0% by weight of the hydroalcoholic extraα of barberry, wherein the extraα from about 4.8% to about 7.2% by weight of berberine; and
(M) from about 2.0% to about 3.0% by weight of the hydroalcoholic extraα of scutellariae baicalensis; further wherein the composition comprises: (i) the supercritical carbon dioxide extraα of ginger and the post-supercritical carbon dioxide hydroalcohohc extraα of ginger at avweight ratio of from about 0.9 to about 1.4 parts of supercritical carbon dioxide extraα per 1 part of post- 20 Doc.607322
9510.101G
supercritical carbon dioxide hydroalcohohc extraα; (ii) the hydroalcohohc extraα of turmeric and the supercritical carbon dioxide extraα of turmeric at a weight ratio of from about 8 to about 12 parts of hydroalcohohc extraα per 1 part of supercritical carbon dioxide extraα; and (hi) the supercritical carbon dioxide extraα of rosemary and the hydroalcohohc extraα of rosemary at a weight ratio of from about 1.6 to about 2.4 parts of supercritical carbon dioxide extraα per 1 part of hydroalcohohc extraα.
42. A method according to claim 23, wherein step (2) comprises orally administering the composition in a daily dosage of at least about 700 mg.
43. A method according to claim 23, wherein step (2) comprises orally administering the composition on a daily basis for at least 4 weeks.
21
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PCT/US2002/009477 2001-04-05 2002-03-28 Improved anti-inflammatory herbal composition and method of use WO2002080682A1 (en)

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CA2442964A CA2442964C (en) 2001-04-05 2002-03-28 Improved anti-inflammatory herbal composition and method of use
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DE60228560T DE60228560D1 (en) 2001-04-05 2002-03-28 ANTI-INFLAMMATORY HERB PREPARATION
JP2002578730A JP4518740B2 (en) 2001-04-05 2002-03-28 Improved anti-inflammatory herbal compositions and methods of use
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CN1265712C (en) 2006-07-26
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CA2442964A1 (en) 2002-10-17
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HK1064256A1 (en) 2005-01-28
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AU2002257094B2 (en) 2007-09-13
EP1383386A1 (en) 2004-01-28
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